Amytrx has commenced the Phase II clinical trial of its lead drug candidate, AMTX-100 CF3, to treat atopic dermatitis (AD).
A peptide, AMTX-100 CF3 is in a topical ointment formulation that penetrates the skin easily.
Made of 87% water, it leaves no odour or residue.
AMTX-100 CF3 is claimed to have the potential to transport across membranes, addressing inflammation and modulating immune-mediated ailments than just hindering inflammation.
Amytrx is launching the trial in adult participants with mild to moderate atopic dermatitis utilising transcriptomic mapping.
Amarex Clinical Research designed the trial, which will assess the safety and efficacy of AMTX-100 CF3 over 28 days.
The company also filed an investigational new drug (IND) application with the Food and Drug Administration (FDA), guided Amytrx through the Phase I trial and is set to lead the product through FDA trials until it receives approval for marketing.
Amytrx intends to expand to adolescent and juvenile participants during its Phase II trial depending on the safety profile of AMTX-100 CF3 in Phase I/II.
The companies concluded the Phase I human safety and exploratory efficacy trial of the drug last year.
According to the trial data, 50% of the patients in a seven-day treatment protocol attained total or almost total clearance of treated AD lesions following one week of AMTX-100 CF3 administration.
In addition, the improvement trend continued even after concluding the treatment as well as through the two-week follow-up period.
Amytrx chief business officer Randy Riggs said: “We are encouraged by the biological impact on patients in this study for their treatment with a therapeutic we believe is not only effective but is supportive of compliance.”
“We’re excited by the potential of our peptide therapeutic that doesn’t inhibit, but safely modulates inflammation to bring about the resolution of immune-mediated diseases.”